[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-134838-en":3,"doc-seo-134838-105":31,"detail-sidebar-cat-0-en-105":92},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":20,"is_deleted":4,"is_public":21,"is_downloadable":21,"audit_status":21,"page_count":22,"language":23,"language_code":24,"site_id":25,"html_lang":24,"table_of_contents":26,"faqs":27,"seo_title":28,"seo_description":14,"update_tm":29,"read_time":30},134838,7971461740909,"Levi","https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d",7,"Healthcare","Novantrone - 批准函（补充申请/孤儿药指定）","Approval package letters from the Center for Drug Evaluation and Research address Immunex Corporation’s new drug application and supplemental approval for Novantrone (mitoxantrone for injection concentrate). The correspondence confirms safe and effective use when administered in combination with corticosteroids as initial chemotherapy for pain related to advanced hormone-refractory prostate cancer, and provides requirements for final printed labeling and promotional materials submissions. A separate letter grants orphan drug designation for mitoxantrone for hormone-refractory prostate cancer and outlines obligations regarding orphan exclusivity notifications and annual development status updates.","# CENTER FOR DRUG EVAILUATION AND RESEARCH\n\nAPPROVAL PACKAGE for:  \nAPPLICATION NIJMBER:019297/S014             \nTRADE NAME:Novantrone              \nGENERIC NAME:Mixtoxantrone for injection concentrate  \n  Immunex Corporation          \nSPONSOR:  \nAPPROVALDATE:   11/13/96                \nFood and Drug AdministrationRockville MD 20857  \nImmunex Corporation51University StreetSeattle,Washington 98101-2936  \n3V1 I9CS  \nAttention:Mark W.GauthierSenior Regulatory Affairs Manager  \nDear Mr.Gauthier:  \nPlease refer to your May 10,1996 new drug application submitted under section 505(b)of theFederal Food,Drug,and Cosmetic Act for Novantrone(mitoxantrone for injectionconcentrate).  \nWe acknowledge receipt of your amendments dated July 10;August 16;September 6 and 19;October 1,3,11,18 and 31;and November 11,1996.  \nThis new drug application provides for the use of Novantrone in combination withcorticosteroids as initial chemotherapy for the treatment of patients with pain related toadvanced hormone-refractory prostate cancer.  \nWe have completed the review of this supplemental application,including the submitted draftlabeling,and have concluded that adequate information has been presented to demonstrate thatthe drug product is safe and effective for use as recommended in the enclosed marked-up draftlabeling.Accordingly,the application is approved effective on the date of this letter.  \nThe final printed labeling (FPL)must be identical to the enclosed marked-up draft labeling.  \nPlease submit sixteen copies of the FPL as soon as it is available,in no case more than 30 daysafter it is printed.Please individually mount ten of the copies on heavy weight paper orsimilar material.For administrative purposes this submission should be designated \"FINALPRINTED LABELING\"for approved NDA 19-297/S-014.Approval of this submission byFDA is not required before the labeling is used.  \nShould additional information relating to the safety and effectiveness of the drug becomeavailable,revision of that labeling may be required.  \nIn addition,please submit thre copies of the introductory promotional material that youpropose to use for this product.All proposed materials should be submitted in draft or mock-up form,not final print.Please submit one copy to this Division and two copies of both thepromotional material and the package insert directly to:  \nFood and Drug Administration  \nDivision of Drug Marketing,Advertising and Communications,HFD-40  \n5600 Fishers LaneRockville,Maryland 20857  \nWe remind you that you must comply with the requirements for an approved NDA set forthunder 21 CFR 314.80 and 314.81.  \nIf you have any questions,please contact Leslie Vaccari,Project Manager,(301)594-5778.  \nRelu4从f4  \n   1-3-96  \nRobert J.DeLap,M.D.,Ph.D.Director  \nDivision of Oncology Drug ProductsOffice of Drug Evaluation ICenter for Drug Evaluation and Research  \nENCLOSURE:Labeling  \nNDA19-297/S-014Page 3  \nCc:  \nOriginal NDA 19-297HFD-150/Div.filesHFD-2/M.LumpkinHFD-101/L.CarterHFD-810/C.HoibergDISTRICT OFFICEHFD-80(with labeling)  \nHFD-35/PVaccari(with labeling)HFD-40/DDMAC/TAcker(with labeling)HFD-613(with labeling)HFD-021/J.Treacy(with labeling)HFD-150/LVaccari(with labeling)HFD-150/JBeitz(with labeling)HFD-150/GeWilliams(with labeling)HFD-150/RBarron(with labeling)HFD-150/TKoutouskos(with labeling)HFD-150/DPease(with labeling)  \nDrafted by:LVaccari/11-9-96/FT:11-13-96R/D Init.by:DPease/11-12-96,11-1子-96   \nJBeitz/11-13-96  \nRJustice/11-13-96  \nRBarron/11-13-96  \nRWood/11-13-96  \nGeWilliams/11-12-96  \nARahman/11-13-96  \nJDeGeorge/11-13-96  \nTKoutsoukos/11-12-96  \nCGnecco/11-12-96  \nfinal:  \nAPPROVAL(Efficacy Supplement/S-014)  \nOffice of Orphan Products Development(HF-35)Food and Drug Administratior 5600 Fishers LaneRockville,MD 20857  \nAugust 21,1996  \nImmunex Corporation  \nAttention:Mr.Mark W.GauthierSenior Manager,Regulatory Affairs51 University StreetSeattle,WA 98101  \nDear Mr.Gauthier:  \nReference is made to your orphan drug application of April 3,1996 submi","cbCaidL03gZ45HHb","https://ap.wps.com/l/cbCaidL03gZ45HHb","pdf",16286292,4,1,382,"English","en",105,"# Approval Package\n## New Drug Application Supplemental Approval (NDA 19-297/S-014)\n## Final Printed Labeling and Promotional Materials\n## Orphan Drug Designation Notification","[{\"question\":\"该批准函确认了Novantrone的哪些用途？\",\"answer\":\"函件确认Novantrone与糖皮质激素联合用作晚期激素难治性前列腺癌患者疼痛相关的初始化疗方案的用途，并认定药品按附件标注推荐使用时具备安全性与有效性所需的充分信息。\"},{\"question\":\"最终印刷标签（FPL）需要满足什么要求？\",\"answer\":\"最终印刷标签必须与所附标注的修订草案保持一致，并要求按规定份数提交，同时在行政用途上指定为“FINAL PRINTED LABELING”。\"},{\"question\":\"孤儿药指定信中对申请方有哪些后续义务？\",\"answer\":\"指定信要求在行使孤儿药独占性意向时提交书面通知，并在开发项目状态方面至少按年度告知该办公室；同时在提交后续营销申请时需对应孤儿指定用途进行指示与必要的数据补充。\"}]","Novantrone - 批准函（补充申请/孤儿药指定） | PDF",1787300223,963,{"code":4,"msg":32,"data":33},"ok",{"site_id":25,"language":24,"slug":34,"title":13,"keywords":35,"description":14,"schema_data":36,"social_meta":87,"head_meta":89,"extra_data":91,"updated_unix":29},"novantrone-approval-letter-supplemental-application-orphan-drug-designation","",{"@graph":37,"@context":86},[38,54,69],{"@type":39,"itemListElement":40},"BreadcrumbList",[41,45,49,52],{"item":42,"name":43,"@type":44,"position":21},"https://docshare.wps.com","Home","ListItem",{"item":46,"name":47,"@type":44,"position":48},"https://docshare.wps.com/document/","Document",2,{"item":50,"name":12,"@type":44,"position":51},"https://docshare.wps.com/document/healthcare/",3,{"item":53,"name":13,"@type":44,"position":20},"https://docshare.wps.com/document/novantrone-approval-letter-supplemental-application-orphan-drug-designation/134838/",{"url":53,"name":13,"@type":55,"author":56,"headline":13,"publisher":58,"fileFormat":61,"inLanguage":24,"description":14,"dateModified":62,"datePublished":63,"encodingFormat":61,"isAccessibleForFree":64,"interactionStatistic":65},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":42,"name":59,"@type":60},"DocShare","Organization","application/pdf","2026-08-27","2026-08-21",true,{"@type":66,"interactionType":67,"userInteractionCount":20},"InteractionCounter",{"@type":68},"ViewAction",{"@type":70,"mainEntity":71},"FAQPage",[72,78,82],{"name":73,"@type":74,"acceptedAnswer":75},"该批准函确认了Novantrone的哪些用途？","Question",{"text":76,"@type":77},"函件确认Novantrone与糖皮质激素联合用作晚期激素难治性前列腺癌患者疼痛相关的初始化疗方案的用途，并认定药品按附件标注推荐使用时具备安全性与有效性所需的充分信息。","Answer",{"name":79,"@type":74,"acceptedAnswer":80},"最终印刷标签（FPL）需要满足什么要求？",{"text":81,"@type":77},"最终印刷标签必须与所附标注的修订草案保持一致，并要求按规定份数提交，同时在行政用途上指定为“FINAL PRINTED LABELING”。",{"name":83,"@type":74,"acceptedAnswer":84},"孤儿药指定信中对申请方有哪些后续义务？",{"text":85,"@type":77},"指定信要求在行使孤儿药独占性意向时提交书面通知，并在开发项目状态方面至少按年度告知该办公室；同时在提交后续营销申请时需对应孤儿指定用途进行指示与必要的数据补充。","https://schema.org",{"og:url":53,"og:type":88,"og:title":13,"og:site_name":59,"og:description":14},"article",{"robots":90,"canonical":53},"index,follow",{"doc_id":7,"site_id":25},{"code":4,"msg":5,"data":93},[94,98,102,106,111,116,119,124,129,132,136],{"id":21,"doc_module":4,"doc_module_name":47,"category_name":95,"show_sort_weight":96,"slug":97},"Story & Novel",90,"story-novel",{"id":48,"doc_module":4,"doc_module_name":47,"category_name":99,"show_sort_weight":100,"slug":101},"Literature",80,"literature",{"id":20,"doc_module":4,"doc_module_name":47,"category_name":103,"show_sort_weight":104,"slug":105},"Exam",70,"exam",{"id":107,"doc_module":4,"doc_module_name":47,"category_name":108,"show_sort_weight":109,"slug":110},5,"Comic",60,"comic",{"id":112,"doc_module":4,"doc_module_name":47,"category_name":113,"show_sort_weight":114,"slug":115},6,"Technology",50,"technology",{"id":11,"doc_module":4,"doc_module_name":47,"category_name":12,"show_sort_weight":117,"slug":118},40,"healthcare",{"id":120,"doc_module":4,"doc_module_name":47,"category_name":121,"show_sort_weight":122,"slug":123},8,"Research & Report",30,"research-report",{"id":125,"doc_module":4,"doc_module_name":47,"category_name":126,"show_sort_weight":127,"slug":128},9,"Religion & Spirituality",20,"religion-spirituality",{"id":127,"doc_module":4,"doc_module_name":47,"category_name":130,"show_sort_weight":127,"slug":131},"World Cup","world-cup",{"id":133,"doc_module":4,"doc_module_name":47,"category_name":134,"show_sort_weight":133,"slug":135},10,"Lifestyle","lifestyle",{"id":137,"doc_module":4,"doc_module_name":47,"category_name":138,"show_sort_weight":107,"slug":139},19,"General","general"]